Study Results
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View full resultsBasic Information
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COMPLETED
NA
155 participants
INTERVENTIONAL
2023-05-23
2023-10-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Clareon Vivity/Vivity Toric
Previous implantation in both eyes with Clareon Vivity/Vivity Toric Extended Vision IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation
Clareon Vivity/Vivity Toric Extended Vision IOL
Extended vision intraocular lens implanted in the capsular bag of the eye during cataract surgery. IOLs are intended for long term use over the lifetime of the cataract patient.
Clareon Monofocal/Clareon Toric
Previous implantation in both eyes with Clareon Monofocal/Clareon Toric IOL (intraocular lens), with previous implantation defined as 90-180 days post second eye implantation
Clareon Monofocal/Clareon Toric IOL
Single vision intraocular lens implanted in the capsular bag of the eye during cataract surgery. IOLs are intended for long term use over the lifetime of the cataract patient.
Interventions
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Clareon Vivity/Vivity Toric Extended Vision IOL
Extended vision intraocular lens implanted in the capsular bag of the eye during cataract surgery. IOLs are intended for long term use over the lifetime of the cataract patient.
Clareon Monofocal/Clareon Toric IOL
Single vision intraocular lens implanted in the capsular bag of the eye during cataract surgery. IOLs are intended for long term use over the lifetime of the cataract patient.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Previously implanted in both eyes with Clareon Vivity/Clareon Vivity Toric or Clareon Monofocal/Clareon Toric IOLs for at least 3 months and up to 6 months (90 to 180 days) after second eye implant.
Exclusion Criteria
* Subjects who were targeted to monovision defined as ≥ 1.50 Diopter (D) of anisometropia.
* Clinically significant PCO (posterior capsule opacification) affecting vision.
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Lead, Surgical CRD
Role: STUDY_DIRECTOR
Alcon Research, LLC
Locations
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Wolstan Goldberg Eye Associates
Torrance, California, United States
Eye Center of Northern Colorado, PC
Fort Collins, Colorado, United States
Grosinger, Spigelman & Grey Eye Surgeons, P.C.
Bloomfield Hills, Michigan, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Eye Care Specialists
Kingston, Pennsylvania, United States
Carolina Eyecare Physicians LLC
Mt. Pleasant, South Carolina, United States
Vance Thompson Vision
Sioux Falls, South Dakota, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ILE632-C002
Identifier Type: -
Identifier Source: org_study_id
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